On September 27, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported an overview of the comprehensive immune monitoring data from the Phase 2 Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) at the 2nd World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies in Norfolk, VA (Press release, OncoSec Medical, SEP 27, 2017, View Source [SID1234520665]). The trial assessed the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab in patients with unresectable metastatic melanoma and its ability to convert “cold” to “hot” tumors.
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In a plenary lecture entitled: “In situ priming with concurrent immune checkpoint inhibition: A phase 2 clinical trial of intratumoral plasmid IL-12 with electroporation in combination with pembrolizumab,” Alain Algazi, MD, Principal Investigator from UCSF, will discuss the clinical data presented at ASCO (Free ASCO Whitepaper)-SITC earlier this year, demonstrating that ImmunoPulse IL-12 in combination with pembrolizumab is well-tolerated and yields clinically meaningful synergy in immunologically “cold” tumors. Furthermore, translational data will be shown that suggest that therapeutic strategies depleting regulatory T-cells may enhance anti-tumor immunity potentially leading to additional improvements in objective response rates (ORR).
“These data support our planned phase 2b registration-directed trial, PISCES, which is designed to demonstrate that the combination of ImmunoPulse IL-12 and pembrolizumab provides an opportunity to address the resistance to anti-PD-1 therapy in the melanoma patient population,” said Punit Dhillon, CEO and President at OncoSec. “Patients with metastatic melanoma who are progressing or have progressed on anti-PD-1 therapy have limited treatment options and we look forward to presenting further data from our recently completed trials at a future medical conference later this year.”
Earlier in the week, Adil Daud, MD, Chief Clinical Strategist at OncoSec and Professor of Medicine at the University of California, San Francisco, gave an oral presentation at the 2nd World Congress of Electroporation titled, “Local and Systemic Immunotherapy by Electroporation,” which provided an overview of the development of OncoSec’s Phase 2 clinical studies assessing ImmunoPulse IL-12 as a monotherapy in patients with metastatic melanoma.
Shawna Shirley, Ph.D., Senior Scientist at OncoSec, also gave an oral presentation at the 2nd World Congress of Electroporation entitled, “Intratumoral Electroporation of Plasmid IL-12 Using Modified Parameters and an Optimized DNA Plasmid Increases Immunogenicity in Untreated Lesions in Mice,” which provided an overview of the improved preclinical efficacy using an optimized IL-12 plasmid and the novel TRACETM-enabled DNA electroporation device.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)
PISCES is a planned, global, multicenter phase 2b, open-label trial of intratumoral pIL-12 (tavokinogene telseplasmid or “tavo”) plus electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of ImmunoPulse IL-12 in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR) in anti-PD-1 non-responder patients.
For more information please visit our website at www.oncosec.com.